Hair restorer containing vetiver grass extract

ABSTRACT

The present invention includes methods for the treatment and/or prevention of hair loss and methods for the regeneration or restoration of hair growth comprising a step of identifying an individual suffering from or susceptible to hair loss or hair thinning or in need of hair regeneration, and a step of administering an extract of the root of a Vetiver grass. Preferably, the extract is an aqueous extract and is administered topically. Also preferably, the Vetiver grass is a subspecies of  Vetiveria zizanioides , and is most preferably  Vetiveria zizanioides  (L) Nash. The present invention also provides a composition, preferably in the from of a lotion, gel, cream, or other suspension, and a distinct chemical compound or class of chemical compounds therein, effective in restoring hair growth, preventing hair loss, and/or reversing the effects of hair thinning. The composition may include an effective amount of a hair loss preventative or hair growth promoting composition isolatable as an extract of the roots of a Vetiver grass, together with a pharmaceutically-acceptable topical carrier other than water.

PRIORITY CLAIM

[0001] The present application claims priority from, and is acontinuation of, the following co-pending application: U.S. applicationSer. No. 09/318,665, which was filed May 25, 1999, and issued as U.S.Pat. No. _,___,___ on Feb. 27, 2001.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention

[0003] The present invention relates to a composition containing anextract of Vetiver grass, having the effect of increasing or restoringhair growth, and/or preventing hair loss. More specifically, the presentinvention relates to a hair growth restoring and/or hair loss preventingcomposition containing an extract of the root of the plant Vetiveriazizanioides.

[0004] 2. Description of the Related Art

[0005] Efforts to Restore Hair Growth and/or Prevent Hair Loss

[0006] The recorded literature, including the medical, scientific andpatent literature, relates various efforts to treat and/or prevent hairloss and to restore and/or encourage hair growth, particularly regardinghair on the human scalp. Some of these efforts have met with varyingdegrees of success, ranging from complete failure to more-recentlyavailable topically administered drugs such as Rogaine® (activeingredient, minoxidil) and orally administered drugs such as Propecia®(active ingredient, finasteride). The active ingredients in these twodrugs have been approved by the United States Food and DrugAdministration for promoting hair growth. Rogaine® and Propecia® exhibitsome degree of success in promoting and/or restoring hair growth,particularly hair loss at the vertex or crown of the head, butadministration of these drugs may lead to certain adverse side effects,including for example sexual dysfunction. Moreover, Rogaine® andPropecia® are to be used on a continual basis and are relativelyexpensive. Accordingly, individuals with thinning hair or hair loss, orindividuals likely to experience thinning hair or hair loss, especiallymen with thinning hair or hair loss on the scalp or, more particularly,on the vertex of the head, are in need of alternative treatments toencourage and/or restore hair growth.

[0007] Accordingly, there have been a variety of efforts to fulfill thisneed. As evidence of these efforts, the PTO has granted approximately100 patents on methods and or compositions for treating hair loss and/orthinning hair. Among these patent are patents that disclose baldnessremedies made from botanical, vegetative, or other found materials. Forexample, these patents include U.S. Pat. No. 5,679,378 (for the topicaluse of dead sea mud); U.S. Pat. No. 5,744,128 (for the topical use ofemu oil); U.S. Pat. No. 5,665,342 (for the topical use of potatopeelings and lantana leaves); U.S. Pat. No. 5,597,575 (for the topicaluse of vitamin D3 and aloe); U.S. Pat. No. 5,674,510 (for the topicaluse of garlic powder, brewers yeast, grapefruit, acidic acid and kelp);U.S. Pat. No. 5,750,108 (for the topical use of tea tree oil, chlorinedioxide and acidic solution and saw palmetto berry extract); U.S. Pat.No. 5,695,748 (for the topical use of sage, aloe and nettles, castoroil, shea butter, wheat germ oil and white iodine) and U.S. Pat. No.5,494,667 (for the topical use of pine extract and bamboo extract orJapanese apricot). The United States Food and Drug Administration hadnot determined whether these methods and/or compositions of treatinghair loss and restoring hair growth are uniformly safe and effective.

Vetiver Grass

[0008] There are at least seventeen known varieties of Vetiver grass,the most common of which is Vetiveria zizaniodes. The taxonomicinformation of the Vetiver grasses, which are often also genericallyreferred to as Vetiveria Bory, is as follows: Family-Graminae (Poaceae);Subfamily-Panicoideae; Tribe-Andropogoneae; subtribe-Sorghinae. Vetivergrasses are common to flood plains and stream banks and are genericallydescribed as follows: They are tufted perennials, having a line of hairsat the ligule; the inflorescence is a panicle. The primary branches ofthe panicle are whorled, simple, and each bears a raceme. The raceme istypically long and slender, comprising (20)3-10 spikelet pairs. Thespikelet are sessile and laterally compressed, and the plant's callus isobtuse to pungent, and is often large and concical. The lower glume ischartaceous to coriaceous, spinulose, and the upper glume is shortlyawned. See, e.g., Watson, L. and M. J. Dallwitz (1989) Grass Genera ofthe World, Australian National University Printing Service, Canberra.Further information regarding the Vetiver grasses may be obtained fromThe Vetiver Network at 15 Wirt Street NW, Leesburg Va. 20176 USA, phone:(703) 771-1942, facsimile: (703) 771-8260 (Email: vetiver@vetiver.org;Home page: http://www.vetiver.org/).

[0009] Specimens of the Vetiveria zizaniodes (L.) Nash subspecies ofVetriver grass have been identified in Paraguay (in the State ofParaguari) by David R. Brenner at 250 m, 25.54 S 54.09 W and by ElissaZardini and C. Cuevas at 500 m, 25.54 S 54.09 W, and in Peru (in theState of Loreto) by W. H. Lewis, M. Elvin-Lewis, M. C. Gnerre, and C.Diaz at 160 m, 3.15 S 25.50 W. According to the reports of W. H. Lewiset al., the native people in the State of Loreto in Peru, who identifythe Vetiveria zizaniodes (L.) Nash subspecies by the name “pachuli,”crush the root and rhizome, and use the obtained juice to wash theirhair. These native people are also reported to have boiled the root, andused the decoction to wash their hair. In other acounts, the roots ofthis plant have also been reported to have been used by the nativepeople of Loreto as a medicine to treat, among other conditions,dermatitis, hemorrhoids, fever, rheumatism, and neuralgia, and have beenused for the control of fungal growth. However, use to prevent hair lossor to facilitate hair growth is not known.

SUMMARY OF THE INVENTION

[0010] The present invention includes methods for the treatment and/orprevention of hair loss and methods for the regeneration or restorationof hair growth comprising a step of identifying an individual sufferingfrom or susceptible to hair loss or hair thinning or in need of hairregeneration, and a step of administering an extract of the root of aVetiver grass. Preferably, the extract is an aqueous extract and isadministered topically. Also preferably, the Vetiver grass is asubspecies of Vetiveria zizaniodes, and is most preferably Vetiveriazizaniodes (L.) Nash. The present invention also provides a composition,preferably in the from of a lotion, gel, cream, or other suspension, anda distinct chemical compound or class of chemical compounds therein,effective in restoring hair growth, preventing hair loss, and/orreversing the effects of hair thinning. The composition may include aneffective amount of a hair loss preventative or hair growth promotingcomposition isolatable as an extract of the roots of a Vetiver grass,together with a pharmaceutically-acceptable topical carrier other thanwater.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[0011] One object of the present invention is to provide a non-toxichair growth restorer and/or hair loss preventer. Another object of thepresent invention is to provide a relatively inexpensive hair growthrestoring composition or hair loss preventing composition, including acompound or class of compounds having the effect of restoring hairgrowth and/or preventing hair loss. Another objective of the presentinvention is to provide an ingestable, injectable, ortopically-applicable composition for restoring hair growth and/orpreventing hair loss. Yet another object of the present invention is toprovide a renewable resource for a hair growth restorer or hair losspreventing compound or class of compounds. It shall be understood thatthe invention as described and claimed herein should optimally satisfymore than one of the objects of the present invention, but need notsimultaneously satisfy all, or even one, of the objects of the presentinvention, nor need it satisfy any particular object of the invention.

[0012] As used herein, the terms “restore hair growth,” “hair restorer,”and “to restore hair growth” are essentially interchangeable. Eachrefers to methods or compositions for increasing the amount of hairgrowth. These phrases do not necessarily refer to the production of afull head of hair, nor do they refer to the restoration of hair growthto the state before the onset of hair loss or hair thinning. Moreprecisely, these phrases and specifically the phrase “restore hairgrowth” should be interpreted consistently with their uses in U.S. Pat.Nos. 5,695,748, 5,679,378, and 5,578,599, the disclosures of which areincorporated by reference herein. Most typically, although notexclusively, “restore hair growth” refers to increasing the amount ofhair growth at the vertex or crown of the head or at the front of thehair near the hair line, and most typically, although not exclusively,refers to human males.

[0013] As used herein, the terms “prevent hair loss,” “hair losspreventer,” and “to prevent hair loss” are essentially interchangeable.Each refers to methods or compositions for preventing the degree of hairloss. “Hair loss,” as that term is used herein, includes hair thinning.These phrases do not necessarily refer to the complete cessation of hairloss or of hair thinning; rather, they refer to any measurable slowingin the rate of hair loss, as measured by standard measurements such asfollicle count per unit skin area or by mass of hair per unit skin area.Such hair loss may be brought on by any of a variety of conditions, aswill be understood by those of skill in the art. These phrases shouldnot be interpreted inconsistently with the phrase “restore hair growth”,as used in U.S. Pat. Nos. 5,695,748, 5,679,378, and 5,578,599. Mosttypically, although not exclusively, “prevent hair loss” refers topreventing the amount of hair lost at the vertex or crown of the head orat the front of the hair near the hair line, and most typically,although not exclusively, refers to human males.

[0014] As used herein, the phrases “hair loss” and “thinning hair,” bothrefer to the state in which fewer hair follicles per unit area (haircount) on the skin are produced than in a state prior to the onset ofhair loss or hair thinning, and may also refer to the state in whichless mass of hair per unit skin area is produced than in a state priorto the onset of hair loss or hair thinning. Most typically, although notexclusively, “hair loss” refers to the amount of hair at the vertex orcrown of the head or at the front of the hair near the hair line, andmost typically, although not exclusively, refers to human males.

[0015] As used herein, the generic terms “Vetiver grass” or “Vetivergrasses” or “Vetiveria Bory” refer to the plants known and referred toas members of the Family Graminae (Poaceae), the Subfamily Panicoideae,the Tribe Andropogoneae; and the Subtribe Sorghinae. Specific,currently-known examples of Vetiver grasses include the Vetiveriazizaniodes subspecies, Vetiveria zizaniodides (L.) Nash, Small, Fl.Southeast U.S. 67, 1326 (1903), and Vetiveria zizaniodides (L.) Nashvar. tonkinensis, A. Camus, Bull. Mus. Nat. Hist. 25:674 (1919). Vetivergrasses also include the following species: Vetiveria arguta, (Steud.)C. E. Hubb., Kew Bull. Misc. Inf. 1939:654 (1939); Vetiveria elongata,(R.Br.) Stapf, Kew Bull. Misc. Inf. 1934:44 (1944); Vetiveria filipes,(Benth.) C. E. Hubb., Kew Bull. Misc. Inf. 1394L44 (1944); Vetiveriafilipes, (Benth.) C. E. Hubb. var. arundinacea (Reeder) Jansen, ActaBot. Neerl. 2:286 (1953); Vetiveria fulvibarbis, (Trin.) Stapf, Fl.Trop. Afr. 9:158 (1917); Vetiveria intermedia, S. T. Blake, Queensl.Univ. Dept. Biol. Papers 2(3):21 (1944); Vetiveria lawsoni, (Hook.f.)Blatter & McCann, Journ. Bombay Not.Hist.Soc. 32:409 (1928); Vetiverianigritana, (Benth.) Stapf, Fl. Trop. Afr. 9:157 (1917); Vetiveriapauciflora, S. T. Blake, Queensl. Univ. Dept. Biol. Papers 2(3):20(1944); Vetiveria rigida, B. K. Simon, Austrobaileya 3(1):95 (1989), andmay also include: Vetiveria arundinacea, Vitiveria festucoides,Vetiveria muricata, Vetiveria odorata, and Vetiveria odovatissima Bory.Furthermore, the Vetiver grasses may include Vetiveria venustus andVetiveria nemoralis, but these species are also typically categorizedas, respectively, Hemisorghum venustus and Chrysopogen nemoralis.

[0016] The most common of the known varieties of Vetiver grass isVetiveria zizanioides. Among the known subspecies of Vetiveriazizaniodes is the subspecies Vetiveria zizaniodes (L.) Nash. A specimenof this subspecies has been identified in Paraguay (in the State ofParaguari) by David R. Brenner at 250 m, 25.54 S 54.09 W and by ElissaZardini and C. Cuevas at 500 m, 25.54 S 54.09 W. Furthermore, a specimenof this subspecies has been identified in Peru (in the State of Loreto)by W. H. Lewis, M. Elvin-Lewis, M. C. Gnerre, and C. Diaz at 160 m, 3.15S 25.50 W.

[0017]Vetiveria zizaniodes (L.) Nash is described as follows: It is adensely tufted, awnless, wiry, glabrous perennial grass. The plant growsin large clumps from a much-branched root stock with erect culms 0.5-1.5meters high. The leaf blades are relatively stiff, long and narrow,usually up to 75 centimeters long and 8 millimeters or less in width,and glabrous but “downward rough” along the edges. The panicles aretypically 15-30 centimeters long, and are narrow, acute, appressed,awnless, with one sessile spikelet; they are hermaphroditic, somewhatflattened laterally, and typically have short sharp spines, threestamens, and two plumose stigmas; the other spikelets are pedicelled andstaminate. Some cultivated forms seldom flower. Furthermore, the leavesare basal and cauline. The blades are elongate, to 0.8 meters long,thick, and usually conduplicate basally, splitting along midribapically, pubescent basally. They are sometimes purple, marginsrevolute, uppermost usually with vitreous spines; sheaths glabrous;ligule a fringe of hairs, 0.3-1.0 millimeters long. Inflorescence ofspike-like branches; spike-like branches numerous, racemose, usuallypurple; rachis disarticulating at base of sessile spikelet. Spikeletspaired (1 sessile and perfect, the other pedicellate and neuter orstaminate), dorsally compressed, 2-floreted (upper floret perfect orstaminate, lower floret neuter or staminate). Sessile spikelet is about5 mm long; glumes acuminate, coriaceous, nerveless, about 5 mm long,vitreous, papillose spinose; lemmas acuminate, purple tinged, apexscarious, margins scarious, inrolled, softly ciliate, about 3.5 mm long;paleas scarious, about 2 mm long, margins inrolled, caryopsis not seen.Pedicellate spikelet slightly smaller than sessile spikelet. See, e.g.,World Bank Handbook (1993); Vetiver Grass-A Method of Vegetative Soiland Moisture Conservation, Allen, Charles M. (1980).

[0018]Vetiveria zizaniodes (L.) Nash may be indexed in herbaria underthe following synonyms: Andropogon zizanioides Linn.; Andropogonsquarrosus Hack; Andropogon muricatus Retz.; Andropogon nardus Blanco;Andropogon nigritanus Stapf.; Andropogon festucoides Presl.; Andropogonechinulatum Koenig; Anatherum zizanioides Linn.; Anatherum muricatumBeauv.; Agrostis verticillata Lam; Phalaris zizanioides Linn.

[0019] As used herein, “root” refers to all portions of the subterraneanportion of a specifically or generically identified plant, including,but not limited to, the roots, the rhizomes, and the stolons of theidentified plant.

[0020] As used herein, “individual” refers to any mammal that in a stateunaffected by hair loss, will tend to grow hair. The preferredindividual for use of the treatment and method of the present inventionis a human, and a most preferred individual is a human male afflictedwith adult-onset male pattern baldness. The Stumptail Macaque monkey, aspecies that exhibits a pathogenesis of balding similar to that ofhumans, are another preferred individual. It will be understood by thoseof skill in the art that the Stumptail Macaque monkey may be the subjectof non-human clinical trials of the compositions and methods of thepresent invention.

[0021] As used herein, the term “water” refers to water, preferablypotable water, more preferably spring water, and most preferablypurified water, that is not diluted with a significant amount of alcoholor other water-miscible solvent, and does not have dissolved within it asignificant amount of a water-soluble solute.

[0022] As used herein, the term “isolated” refers to the compound ofclass of compounds of the present invention being free of other,dissimilar compounds with which the compound of the invention isnormally associated in its natural state, so that the compound of theinvention comprises at least 0.5%, 1%, 5%, 10%, or 20%, and mostpreferably at least 50% of the mass, by weight, of a given sample. Sucha sample may be used in the methods of the present invention directed,or may added to particular carriers or diluents as the composition ofthe present invention or when used in the methods of the presentinvention. As used herein, the term “isolatable” means capable of beingisolated.

[0023] Preferred methods of the present invention generally include afirst step of identifying an individual suffering from hair loss or hairthinning, or likely to experience hair loss or hair thinning. One suchcondition, which may be linked to a genetic marker, is known asandrogenetic alopecia. Identification of such a condition, or thelikelihood of experiencing such a condition, may be made by directobservation, as appreciated by those of skill in the art, or byevaluation of the phenotype of an individual's genetic relatives. Aswill be understood by those of skill in the art, an individual'slikelihood of experiencing hair loss generally increases as thatindividual's genetic relatives, most typically the male, maternalgenetic relatives of the individual, are identified as havingexperienced hair loss or hair thinning or, more specifically,androgenetic alopecia. This observation is especially true of humanmales and male Stumptail Macaque monkey, a species that exhibits apathogenesis of balding similar to that of humans, having genetic malerelatives who have experienced hair loss or hair thinning, especiallyadult-onset male pattern baldness. However, it is also true with respectto other individuals and to human females having genetic relatives whohave experienced hair loss or hair thinning. Furthermore, geneticmarkers are identifiable for identifying individuals likely toexperience hair loss of hair thinning; these markers may be used toidentify an individual or the individual's genetic relatives consistentwith the first step of the preferred methods of the present invention.Most preferably, an individual is identified by direct observation ofhair loss or hair thinning over time. Such direct observation may be bythe individual, a member of the individual's family, or by another,including but not limited to hair-care or medical professionals.

[0024] Preferred methods of the present invention generally include asubsequent step of applying or administering a composition comprising anextract of the root of a Vetiver grass. This extract may be either anaqueous extract, an alcoholic extract, or an organic extract. Mostpreferably, the extract is an aqueous extract. More specifically, theVetiver grass root may be extracted from an hydroxylic solvent (e.g.,water, C₁-C₈ alcohols, preferably methanol, ethanol, isopropanol), froma polar aprotic solvent (e.g., acetonitrile, dimethylformamide (DMF),dimethyl sulfoxide, acetone), or from a relatively non-polar organicsolvent (e.g., benzene, toluene, liquid alkanes, preferably C₄-C₈alkanes), or any suitable combination thereof. Salts, detergents, andother additives may be added to these solvents to facilitate extractionas will be appreciated by those of skill in the art.

[0025] The roots may be extracted, for example, within approximately thefollowing weight to volume ratios to solvent: from 1 gram root: 1 litersolvent to 100 gram root: 1 milliliters solvent, and most preferably 1gram root 1 milliliter solvent. The duration of extraction may be asshort a duration as one minute, ten minutes, an hour, overnight, a fullday, a week, and for as long a duration as one month, depending on thesolvent selected and the condition of the root. Furthermore, thesolvent/root mixture may be left at room temperature cooled to anytemperature above the freezing point of the solvent (e.g., 5° C., 10°C., or 20° C, where the solvent is water), and heated (e.g.,approximately 50° C., 60° C., 70° C., 80, 90, or 95° C, where thesolvent is water), or even heated to a boil. If the solvent is boiled,which is not typically preferred, it is preferred that the vapors berefluxed to preserve the active compound or class of compounds of theextract. Also, the root may be left whole, chopped, pureed, blended, orpartly chopped, pureed, or blended prior to or upon addition to thesolvent. Also, the Vetriver grass rhizomes, stolons, or roots may beseparated and separately left whole, chopped, pureed, or blended andthen extracted to yield the compounds or classes of compounds of theinvention. As will be appreciated by those of skill in the art,repeated, sequential extractions in a single or a variety of differentsolvents may be performed. Suitable non-toxic solvents may be selectedfor the final extraction, if a series of extractions is performed.

[0026] Of the hydroxylic solvents, water is most preferred as a solvent.The C₁-C₈ alcohols are also preferred; most preferably among thealcohols are ethanol, methanol, isopropanol, and butanol. Of the polaraprotic solvents, DMF and acetone are most preferred. Of the organicsolvents, benzene and toluene are most preferred.

[0027] The extract of the root of the Vetiver grass may be of any of theVetiver grasses herein described, either generically of specifically. Apreferred species of Vetiver grass is Vetiveria zizaniodes, includingthe Vetiveria zizaniodes (L.) Nash sub-species.

[0028] The preferred hair loss preventing and/or hair growth restoringcomposition of the present invention is a simple aqueous extract of theroot of the Vetiveria zizaniodes plant. In other embodiments, thiscomposition may include, but need not necessarily include,pharmaceutically acceptable carriers that will allow the composition tobe prepared for storage and subsequent administration. Suchcompositions, nonetheless, should contain a pharmaceutically effectiveamount of the compounds or class of compounds of the present invention,in a pharmaceutically acceptable carrier or diluent. Such acceptablecarriers or diluents are described, for example, in Remington'sPharmaceutical Sciences, Mack Publishing Co. (A. R. Gennaro edit. 1985).Preservatives, stabilizers, dyes, flavoring agents (especially where thecomposition is administered orally) or aromatic agents (especially wherethe composition is topically applied) may be provided in thepharmaceutical composition. Also, sodium benzoate, sorbic acid andp-hydroxybenzoic acid esters, antioxidants, and/or suspending agents maybe added as preservatives.

[0029] The preferred compound of class of compounds effective inpreventing hair loss and/or restoring hair growth may be identified andisolated from the root of a Vetiver grass by standard analyticalchemical methods. These methods include, but are not limited to columnelution or column electrophoresis followed by fractionation and chemicaland/or pharmacological analysis of the isolated fractions. The method ofchemical analyses may include, but are not limited to, massspectrometry, liquid-state and/or solid state proton or heteronuclear,one-dimensional or multi-dimensional nuclear magnetic resonancespectroscopy (NMR), ultraviolet spectroscopy, any of a variety ofcrystallographic methods, and any of a variety of other methods known inthe art.

[0030] The safety and efficacy of the preferred compound of class ofcompounds effective in preventing hair loss and/or restoring hair growthmay be established by any of a variety of standard such as animal modelsor human clinical trials. When choosing an appropriate model todetermine efficacy of a method of composition or compound, or class ofcompound of the present invention, the skilled artisan will be capableof choosing an appropriate model, dose, and route of administration, andregime.

[0031] As will be appreciated by those of skill in the art, thepreferred compound of class of compounds effective in preventing hairloss and/or restoring hair growth may be administered via a variety ofmethods, including but not limited to topical administration, as aninjectable, or by oral, rectal or vaginal administration. The preferredmethod of administration is via topical administration directly the skinat the area effected, or likely to be effected by hair loss and/or hairthinning. Compositions for topical administration of for use as aninjectable can be prepared in conventional forms, either as liquidsolutions or suspensions, solid forms suitable for solution orsuspension in liquid prior to injection, or as emulsions. Any of theknown transdermal carriers can further be incorporated into topicalformulations, such as DMSO or azone. Such transdermal carriers, andothers, are known to facilitate delivery of topically-applied activeingredients across the stratum comeum (SC) and/or the stratumgerminativum (SG). Accordingly, a topically applied composition havingthe hair loss preventing or hair growth restoring compound or class ofcompounds of the present invention may be a lotion, gel, or cream, usingpharmaceutically-acceptable carriers, stabilizers, and excipients knownto those of skill in the art.

[0032] Suitable excipients, whether used in topically-administeredcompositions or orally-administered compositions, are, for example,water, saline, dextrose, mannitol, lactose, lecithin, albumin, sodiumglutamate, cysteine hydrochloride, and the like. In addition, ifdesired, the topical of injectable compositions may contain nontoxicauxiliary substances, such as wetting or buffering agents. In practicingthe method of the invention, the compositions can be used alone or incombination with one another, or in combination with other therapeuticor diagnostic agents. For oral administration, the composition may beformulated and used as tablets, capsules or elixirs for oraladministration; for rectal or vaginal administration, as a suppository;for other means of administration, be they as an injectable,parenterally, intravenously, subcutaneously, intramuscularly,colonically, nasally or intraperitoneally, the composition may beformulated as a sterile solution or suspension.

[0033] Furthermore, as will also be appreciated by those of skill in theart, the preferred compound of class of compounds effective inpreventing hair loss and/or restoring hair growth may be chemicallysynthesized, rather than isolated from the root of a Vetiver grass, perse. Thus, while the preferred compound of class of compounds of theinvention, effective in preventing hair loss and/or restoring hairgrowth, are isolatable from the root of a Vetriver grass, the compoundsand class of compounds of the invention may be prepared, purified,and/or isolated in other manners. For example, to synthesize thepreferred compound of class of compounds effective in preventing hairloss and/or restoring hair growth, one of skill in the art willtypically first determine the chemical structure of the preferredcompound of class of compounds. Any of a variety of synthetic methodsmay then be performed, using commercially-available starting materials,to generate the preferred compound or class of compounds in acceptableyields. Pharmaceutically carriers, excipients, stabilizers,preservatives and/or diluents may be added as deemed suitable by thoseof skill in the art.

[0034] The pharmaceutically effective amount of the composition requiredas a dose will depend on the route of administration, and thecharacteristics of the individual being treated. The dose can betailored to achieve a desired effect by those of skill in the art; thedoes will typically depend on such factors as weight, diet, concurrentmedication and other factors which those skilled in the art willrecognize. Typically, doses having the concentration resulting from theaqueous extraction of, for example, Example 1, one tablespoon aliquotsare applied topically from 1 to 42 times per week, including 5, 7, 12,14, 18, 21, 24, 27, 28, 35, 38, and 40 times per week. Most preferably,one tablespoon aliquots are applied four times per day as follows: onceapproximately upon waking in the morning, once approximately at noon,once approximately at 6:00 p.m., and once approximately upon retiring inthe evening.

[0035] As will be appreciated by those of skill in the art, thepreferred compound or class of compounds effective in preventing hairloss and/or restoring hair growth may be administered topically as alotion, gel, cream, or other salves or suspensions. Such lotions, gels,creams, or salves may preferably include agents suitable for cleansingthe skin and/or hair in the affected, treated area.. Such agentsinclude, but are not limited to, soaps, fatty acids, conditioners, andessential oils. Also, suitable thickeners, coloring agents, perfumes,aromatic agents, and/or preservatives may be added to the lotions, gels,creams, or other suspensions or salves as desired by the treatedindividual or the individual's companions. Such agents may be useful indisguising or enhancing the color and odor of the effective compound orclass of compounds extracted or extractable from the Vetiver grass.

[0036] The composition of the present invention may be marketed and/orused in conjunction with shampoos, conditions, styling gels, or otherhair care products. For example, the composition of the presentinvention may be marketed and/or used in conjunction with a shampooand/or a conditioner that improves the appearance or apparent thicknessof hair. The present invention includes, but is not limited to, a methodof cosmetic treatment. More specifically, the present invention includesthe use of an extract of the root of a Vetiver grass in the treatmentand/or the prevention of hair loss, and/or in the restoration or hairgrowth. The present invention also includes, but is not limited to, theuse of an extract of the root of a Vetiver grass for the preparation ofa medicament useful in the treatment and/or the prevention of hair loss,and/or in the restoration or hair growth.. Preferably, the presentinvention encompasses the use of an extract of Vetiver grass for thepreparation of a medicament for the treatment and/or the prevention ofhair loss, and/or in the restoration or hair growth, in a male or femalehuman. Most preferably, the present invention encompasses the use of anextract of the plant Vetiveria zizanlioides (L.) Nash for thepreparation of a medicament for the treatment and/or the prevention ofthe onset of androgenetic alopecia.

[0037] The present invention is described in detail through a variety ofexamples. It will be understood by those skilled in the art that theinvention is not limited to the specific examples provided herein.Furthermore, although specific amounts of plant material and modes ofextraction are specified in the following examples, it will beunderstood by those skilled in the art that the invention is not limitedto these specific amounts and modes, and that variations in the amountof plant material, the mode or duration of extraction, and the method ofadministration, or more specifically, of application to the scalp and orskin, may be varied and still to achieve the desired effect ofincreasing the amount of hair growth and/or preventing hair loss or hairthinning.

EXAMPLE 1 Preparation of an Aqueous Extract

[0038] Approximately 100 grams of the root of the plant Vetiveriazizaniodes (L.) Nash was obtained and washed thoroughly under roomtemperature spring water. The root was allowed to dry for approximatelyone day at room temperature, and was not directly exposed to sunlight.The dried root was placed, fully submerged, into approximately 100milliliters of purified water at room temperature. The mixture was letstand at room temperature for a period of not less than approximately 24hours. The resultant water-based solution contained the aqueous extract.

EXAMPLE 2 Treatment of Human Male with an Aqueous Extract

[0039] An individual human male, approximately 51 years of age, wasidentified as having experienced hair loss on his scalp, in a patterntypical of adult-onset, male-pattern baldness (androgenetic alopecia).The affected area had experienced no visible hair growth for at least 10years, and this individual had not responded to treatment with Rogaine®(topical minoxidol) in the quantity and duration suggested by themanufacturer for a duration of twelve months. The extract, as preparedin Example 1, was applied topically to the affected areas of theindividual's scalp in which hair loss was identified, in the followingmanner. Four times each day, approximately one tablespoon of this liquidwas applied to the affected area, i.e., the crown and top of the scalp,and gently massaged into the skin. After such daily treatment forapproximately three weeks, restored hair growth in the affected areaswas detected.

[0040] At approximately three weeks from the first application, apeach-fuzz-like quantity of hair was detected. At approximately sixweeks, more substantial growth and thickness of the individual's hairfollicles was detected.

EXAMPLE 3 Treatment of Human Male with an Aqueous Extract

[0041] An individual human male, approximately 54 years of age, wasidentified as beginning to experience and likely to experience furtherhair loss on his scalp, in a pattern typical of adult-onset,male-pattern baldness. Certain of this individual's genetic relatives,specifically, his brothers and maternal uncles, had experiencedadult-onset, male-pattern baldness (androgenetic alopecia). An extractof the root of the plant Vetiveria zizaniodes (L.) Nash was preparedsubstantially as described in Example 1. This extract was appliedtopically to the affected areas of the individual's scalp in which hairloss was identified, in the following manner. Each day, approximatelytwo tablespoon of this liquid were applied to the affected area, i.e.,the crown and top of the scalp, and gently massaged into the skin in twoequal portions. Occasionally, the individual also applied the extractwhile washing and rinsing his hair in the typical manner. After suchtreatment for approximately one month, restored hair growth in theaffected area was detected.

[0042] After approximately two years of continual use, the individualhas experienced no additional hair loss, and the individual's hair hascontinued to appear thick.

EXAMPLE 4 Treatment of Human Female with an Aqueous Extract

[0043] An individual human female, approximately 30 years of age, wasidentified as experiencing patches of hair loss and hair thinning on herscalp apparently due to the administration of an unrelated medication.The extract, as prepared in Example 1, was applied topically to theaffected areas of the individual's scalp in which hair loss wasidentified, in the following manner. Four times each day, approximatelyone tablespoon of this liquid was applied to the affected areas andgently massaged into the skin.

[0044] After such daily treatment for approximately two weeks, restoredhair growth in the affected areas was detected.

EXAMPLE 5 Preparation of and Treatment with an Aqueous Extract

[0045] Approximately 100 grams of the root of the plant Vetiveriazizaniodes (L.) Nash is obtained and washed thoroughly under roomtemperature purified water. The root is allowed to dry for approximatelyone day at room temperature. The root is chopped into approximately 5gram pieces, and those pieces are placed into approximately 100milliliters of water that has been heated to a temperature ofapproximately 95° C. The root is placed in the boiling water and allowedto stand for not less than 24 hours.

[0046] An individual human male is identified as having been afflictedwith adult-onset, male pattern baldness. The liquid obtained from theabove-described procedure is applied topically to the affected areas ofthe individual scalp as follows: Once each day, approximately onetablespoon of this liquid is applied to the affected areas, i.e., wherehair loss or hair thinning is identified. This treatment continues fromabout three weeks to about nine weeks.

[0047] Restored hair growth and cessation of hair thinning are detected.

EXAMPLE 6 Preparation of and Treatment with an Alcoholic Extract

[0048] Approximately 100 grams of the root of Vetiveria zizaniodes isobtained and washed thoroughly under room temperature water. The root isallowed to dry for approximately one day at room temperature. The rootis chopped into approximately twenty pieces of approximately equalweight, and those pieces are placed into a mixture of approximately 100milliliters of water and approximately 100 ml of ethanol. This mixtureis let stand at room temperature for a period of at least approximatelyone hour. The liquid is used to treat an individual human maleidentified as having experienced hair thinning as described in Example2.

[0049] Cessation of hair thinning is observed after six weeks oftreatment.

EXAMPLE 7 Preparation and Treatment with an Alcoholic Extract

[0050] Approximately 200 grams of the root of the Vetiveria zizaniodesis obtained and washed thoroughly under room temperature water. The rootis allowed to dry for approximately one day at room temperature. Theroot is pureed and placed into approximately 50 milliliters ofisopropanol at room temperature. This mixture is let stand at roomtemperature for a period of approximately one day. The liquid is used totreat an individual human male with adult-onset male-pattern baldness asdescribed in Example 3.

[0051] Cessation of hair thinning is observed after six weeks oftreatment.

EXAMPLE 8 Preparation of and Treatment with a Polar Aprotic Extract

[0052] Approximately 400 grams of the root of the Vetiveria zizaniodesis obtained and washed thoroughly under room temperature water. The rootis allowed to dry for approximately one day at room temperature. Theroot is pureed and placed into approximately 20 milliliters ofdimethylformamide (DMF). This mixture is let stand at room temperaturefor a period of approximately one day. The liquid is used to treat anindividual human male with adult-onset male-pattern baldness(androgenetic alopecia) as described in Example 2.

[0053] Cessation of hair thinning is observed after six weeks oftreatment.

EXAMPLE 9 Preparation of and Treatment with an Organic Extract

[0054] Approximately 200 grams of the root of the Vetiveria zizaniodesis obtained and washed thoroughly under room temperature water. The rootis allowed to dry for approximately one day at room temperature. Theroot is pureed and placed into approximately 40 milliliters of benzene.This mixture is let stand at room temperature for a period ofapproximately one day. The liquid is used to treat an individual humanmale with adult-onset male-pattern baldness as described in Example 3.

[0055] Cessation of hair thinning is observed after six weeks oftreatment.

What is claimed is:
 1. A composition for treatment or prevention of hairloss comprising: an effective amount of a hair loss preventative or hairgrowth promoting composition isolatable as an extract of the roots of aVetiver grass; and a pharmaceutically-acceptable topical carrier otherthan water.
 2. The composition of claim 1 , wherein the Vetiver grasscomprises at least one subspecies of Vetiveria zizaniodes.
 3. Thecomposition of claim 1 , wherein the Vetiver grass comprises Vetiveriazizaniodes (L.) Nash.
 4. The composition of claim 1 , wherein theextract is an aqueous extract.
 5. The composition of claim 1 , whereinthe extract is selected from the following: an alcoholic extract, apolar aprotic extract, and an organic extract other than an alcoholicextract or a polar apriotic extract.
 6. The composition of claim 1 ,wherein the carrier is an aqueous carrier.
 7. The composition of claim 1, wherein the carrier is a non-aqueous carrier.
 8. The composition ofclaim 1 , wherein the compound is isolated from the root of a Vetivergrass.
 9. The composition of claim 1 , wherein the compound ischemically synthesized.
 10. The composition of claim 1 , wherein thecomposition is selected from a lotion, a gel, and a cream.
 11. Acomposition for treatment of hair loss comprising: an effective amountof a hair loss preventative or hair growth promoting compositionisolatable as an extract of the roots of a Vetiver grass; and apharmaceutically-acceptable topical carrier other than water.
 12. Thecomposition of claim 11 , wherein the Vetiver grass comprises at leastone subspecies of Vetiveria zizaniodes.
 13. The composition of claim 11, wherein the Vetiver grass comprises Vetiveria zizaniodes (L.) Nash.14. The composition of claim 11 , wherein the extract is an aqueousextract.
 15. The composition of claim 11 , wherein the extract isselected from the following: an alcoholic extract, a polar aproticextract, and an organic extract other than an alcoholic extract or apolar apriotic extract.
 16. The composition of claim 11 , wherein thecarrier is an aqueous carrier.
 17. The composition of claim 11 , whereinthe carrier is a non-aqueous carrier.
 18. The composition of claim 11 ,wherein the compound is isolated from the root of a Vetiver grass. 19.The composition of claim 11 , wherein the compound is chemicallysynthesized.
 20. The composition of claim 11 , wherein the compositionis selected from a lotion, a gel, and a cream.